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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033235
Receipt No. R000037893
Official scientific title of the study Evaluate a chair with special structure on back pain : cross over study
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Evaluate a chair with special structure on back pain : cross over study
Title of the study (Brief title) Evaluate a chair with special structure on back pain
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to the subject with lower back pain sit for hours in two kinds of chairs for a long time and evaluate the transition of pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS, questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Sit for 3 hours in the test sample chair and evaluate the degree of back pain
Interventions/Control_2 Sit for 3 hours in the contorol chair and evaluate the degree of back pain
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects who feel strangeness at the waist when sitting in a chair for a long time (about two hours).
2.Subjects who feel painful when sitting in a chair for a long time (around 2 hours).
Key exclusion criteria 1.Currently,Subjects receiving treatment for low back pain
2.Currently, subjects with severe back pain
Target sample size 18

Research contact person
Name of lead principal investigator Masatomo Najima
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization Product Marketing Services International
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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